Steinman Michael A, Bero Lisa A, Chren Mary-Margaret, Landefeld C Seth
San Francisco Veterans Affairs Medical Center and University of California, San Francisco, San Francisco, California 94143, USA.
Ann Intern Med. 2006 Aug 15;145(4):284-93. doi: 10.7326/0003-4819-145-4-200608150-00008.
Internal documents from the pharmaceutical industry provide a unique window for understanding the structure and methods of pharmaceutical promotion. Such documents have become available through litigation concerning the promotion of gabapentin (Neurontin, Pfizer, Inc., New York, New York) for off-label uses.
To describe how gabapentin was promoted, focusing on the use of medical education, research, and publication.
Court documents available to the public from United States ex. rel David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company, mostly from 1994-1998.
All documents were reviewed by 1 author, with selected review by coauthors. Marketing strategies and tactics were identified by using an iterative process of review, discussion, and re-review of selected documents.
The promotion of gabapentin was a comprehensive and multifaceted process. Advisory boards, consultants meetings, and accredited continuing medical education events organized by third-party vendors were used to deliver promotional messages. These tactics were augmented by the recruitment of local champions and engagement of thought leaders, who could be used to communicate favorable messages about gabapentin to their physician colleagues. Research and scholarship were also used for marketing by encouraging "key customers" to participate in research, using a large study to advance promotional themes and build market share, paying medical communication companies to develop and publish articles about gabapentin for the medical literature, and planning to suppress unfavorable study results.
Most available documents were submitted by the plaintiff and may not represent a complete picture of marketing practices.
Activities traditionally considered independent of promotional intent, including continuing medical education and research, were extensively used to promote gabapentin. New strategies are needed to ensure a clear separation between scientific and commercial activity.
制药行业的内部文件为了解药品推广的结构和方法提供了一个独特的窗口。此类文件已通过有关加巴喷丁(Neurontin,辉瑞公司,纽约,纽约)用于非标签用途推广的诉讼而得以公开。
描述加巴喷丁是如何进行推广的,重点关注医学教育、研究和出版的运用。
可从美国联邦政府诉大卫·富兰克林等人案(原告为大卫·富兰克林,被告为辉瑞公司以及华纳 - 兰伯特公司旗下的帕克 - 戴维斯部门)中获取的公开法庭文件,大部分文件时间跨度为1994年至1998年。
所有文件由一位作者进行审阅,部分文件由合著者参与审阅。通过对选定文件进行反复审阅、讨论和再次审阅的迭代过程,确定营销策略和手段。
加巴喷丁的推广是一个全面且多方面的过程。由第三方供应商组织的咨询委员会、顾问会议以及经认可的继续医学教育活动被用于传递推广信息。通过招募当地支持者和与意见领袖互动等方式强化了这些策略,这些人可被用来向其医师同事传达有关加巴喷丁的有利信息。研究和学术活动也被用于营销,鼓励“关键客户”参与研究,利用一项大型研究推进推广主题并建立市场份额,向医学传播公司付费撰写并在医学文献上发表有关加巴喷丁的文章,以及计划压制不利的研究结果。
大多数可得文件由原告提交,可能无法代表营销实践的全貌。
传统上被认为与推广意图无关的活动,包括继续医学教育和研究,被广泛用于推广加巴喷丁。需要新的策略来确保科学活动和商业活动之间有明确的区分。